Substance Dependence
Conditions
Keywords
Substance Dependence, Cognitive-Behavior Therapy, Opiate Dependence, Treatment Moderators
Brief summary
This study is designed to evaluate the relative efficacy of a novel treatment (CBT-IC) versus a standard individual drug-counseling treatment. The novel treatment emphasizes exposure to emotional cues for drug use as part of a comprehensive, yet brief, treatment strategy. These treatments are delivered to opiate-dependent, often poly-substance dependent, individuals in a comprehensive methadone maintenance program who have failed to respond adequately to current treatments.
Detailed description
This study study is designed to test further the efficacy of Cognitive-Behavior Therapy for Interoceptive Cues (CBT-IC - a treatment with a central focus on enhancing a patient's tolerance to the myriad forms of distress-sadness, boredom, anxiety, withdrawal sensations, etc.-that are linked to the stressful lives of drug-dependent individuals, and breaking the link between these emotional cues and drug-related attempts to avoid emotional distress) for intervening with chronically-stressed and treatment-resistant opiate-dependent outpatients. Features of this study of particular relevance to to RFA DA-04-001 include: (1) a focus on opiate-dependent patients undergoing chronic stress; (2) a model for the way in which chronic stress translates into chronic drug use; (2) a focus on the way in which stress-related symptoms serve as trigger for drug use; (3) a focus on both mediators and moderators of treatment that will inform treatment-matching efforts, including a focus on gender differences and emotional avoidance/distress intolerance; and (4) the examination of treatment outcome in a Stage II treatment trial.
Interventions
BEHAVIORALCognitive Behavioral Therapy
12 weekly sessions and 3 booster sessions of cognitive behavioral therapy
BEHAVIORALIndividual Counseling
12 weekly sessions and 3 booster sessions of individual counseling
Sponsors
National Institute on Drug Abuse (NIDA)
Massachusetts General Hospital
Boston University Charles River Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* The primary selection criteria include women and men between the ages of 18 and 65 who: 1. Meet DSM-IV criteria for opiate dependence, 2. Maintain a stable dose of methadone for two weeks prior to recruitment and, 3. a) fail to achieve take-home status for methadone dosing during at least the first four months of methadone treatment, b) test positive on at least two toxicology screens for illicit drugs during the month prior to recruitment c) have never achieved two consecutive toxicology screens free of illicit substances since entering the current treatment episode. 4. Meet study criteria for chronic stress 1. unemployment criteria, and 2. affective disorder criteria.
Exclusion criteria
* (1) Patients with significantly unstable or uncontrolled medical illness which may interfere with participation in treatment (e.g., patients likely to require hospitalization during the study period). (2) Patients with a psychotic or organic mental disorder according to DSM-IV criteria. (3) Patients receiving medication affecting methadone metabolism (e.g. rifampin). (4) Patients with uncontrolled bipolar disorder as evidenced by meeting current criteria for mania or hypomania or meeting criteria for rapid cycling in the last year (as indicated by structured questioning of all patients meeting criteria for bipolar disorder). (5) Patients unable to complete the informed consent or unable to understand study procedures in the informed consent process.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Positive Toxicology Swabs for Illicit Substances | Weekly assessments with summation over three time periods: baseline, treatment, and eight weeks of follow-up. | The primary outcome assessment for this study was the percentage of oral toxicology swabs that were positive of illicit substances. Participants completed these swabs at each assessment point, as well as at each study therapy session. Toxicology swabs were supervised by study staff and used oral specimen collection to screen for opiates, methadone, cocaine, benzodiazepines, amphetamines, THC, and barbiturates. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Addiction Severity Index (ASI) Drug Composite Index | Baseline, Mid Treatment, Treatment Endpoint, Follow-up Evaluation 1, Follow-up Evaluation 2 | The composite score for drug use is determined by answers to 13 questions on the ASI: A/390 + B/390 + C/390 + D/390 + E/390 + F/390 + G/390 +H/390 + I/390 + J/390 + K/390 + L/52 + M/52. A single score is provided, with possible scores ranging from 0 to 1, with higher scores indicate greater drug use. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited via study flyers and postings or were referred to study staff by their substance abuse counselor.
Pre-assignment details
133 individuals were consented. Eleven dropped out prior to SCID administration. At the intake visit, 27 individuals were deemed ineligible. Of the 95 individuals who were eligible, 17 dropped out prior to randomization (7 were discharged, 2 declined treatment, and 8 were lost to contact). A total of 78 individuals were randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| Cognitive Behavior Therapy Psychosocial treatment with an individualized therapy emphasizing interoceptive exposure and training alternative responses to cues for drug use | 41 |
| Individual Drug Counseling Psychosocial treatment with individual drug counseling | 37 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Completed Treatment | Insufficient Treatment | 7 | 11 |
Baseline characteristics
| Characteristic | Individual Drug Counseling | Total | Cognitive Behavior Therapy |
|---|---|---|---|
| Age, Continuous | 42.4 years STANDARD_DEVIATION 10 | 42.3 years STANDARD_DEVIATION 9.9 | 42.2 years STANDARD_DEVIATION 9.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 8 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants | 70 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 25 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 26 Participants | 53 Participants | 27 Participants |
| Region of Enrollment United States | 37 Participants | 78 Participants | 41 Participants |
| Sex: Female, Male Female | 17 Participants | 35 Participants | 18 Participants |
| Sex: Female, Male Male | 20 Participants | 43 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 41 | 0 / 37 |
| serious Total, serious adverse events | 11 / 41 | 11 / 37 |
Outcome results
Primary
Percentage of Positive Toxicology Swabs for Illicit Substances
The primary outcome assessment for this study was the percentage of oral toxicology swabs that were positive of illicit substances. Participants completed these swabs at each assessment point, as well as at each study therapy session. Toxicology swabs were supervised by study staff and used oral specimen collection to screen for opiates, methadone, cocaine, benzodiazepines, amphetamines, THC, and barbiturates.
Time frame: Weekly assessments with summation over three time periods: baseline, treatment, and eight weeks of follow-up.
Population: Randomized participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Behavioral Therapy | Percentage of Positive Toxicology Swabs for Illicit Substances | Baseline Period | 81.3 percentage of positive toxicology screen | Standard Deviation 24.3 |
| Cognitive Behavioral Therapy | Percentage of Positive Toxicology Swabs for Illicit Substances | Treatment Period | 86.2 percentage of positive toxicology screen | Standard Deviation 18.7 |
| Cognitive Behavioral Therapy | Percentage of Positive Toxicology Swabs for Illicit Substances | Follow-Up Period | 77.6 percentage of positive toxicology screen | Standard Deviation 27.4 |
| Individual Drug Counseling | Percentage of Positive Toxicology Swabs for Illicit Substances | Baseline Period | 79.1 percentage of positive toxicology screen | Standard Deviation 33.8 |
| Individual Drug Counseling | Percentage of Positive Toxicology Swabs for Illicit Substances | Treatment Period | 82.3 percentage of positive toxicology screen | Standard Deviation 24.3 |
| Individual Drug Counseling | Percentage of Positive Toxicology Swabs for Illicit Substances | Follow-Up Period | 74.8 percentage of positive toxicology screen | Standard Deviation 30.7 |
Secondary
Addiction Severity Index (ASI) Drug Composite Index
The composite score for drug use is determined by answers to 13 questions on the ASI: A/390 + B/390 + C/390 + D/390 + E/390 + F/390 + G/390 +H/390 + I/390 + J/390 + K/390 + L/52 + M/52. A single score is provided, with possible scores ranging from 0 to 1, with higher scores indicate greater drug use.
Time frame: Baseline, Mid Treatment, Treatment Endpoint, Follow-up Evaluation 1, Follow-up Evaluation 2
Population: Randomized participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Behavioral Therapy | Addiction Severity Index (ASI) Drug Composite Index | Mid Treatment | .20 units on a scale | Standard Deviation 0.07 |
| Cognitive Behavioral Therapy | Addiction Severity Index (ASI) Drug Composite Index | Follow Up 1 | .16 units on a scale | Standard Deviation 0.09 |
| Cognitive Behavioral Therapy | Addiction Severity Index (ASI) Drug Composite Index | Treatment Endpoint | .17 units on a scale | Standard Deviation 0.09 |
| Cognitive Behavioral Therapy | Addiction Severity Index (ASI) Drug Composite Index | Follow-Up 2 | .16 units on a scale | Standard Deviation 0.12 |
| Cognitive Behavioral Therapy | Addiction Severity Index (ASI) Drug Composite Index | Baseline | .23 units on a scale | Standard Deviation 0.09 |
| Individual Drug Counseling | Addiction Severity Index (ASI) Drug Composite Index | Follow-Up 2 | .16 units on a scale | Standard Deviation 0.12 |
| Individual Drug Counseling | Addiction Severity Index (ASI) Drug Composite Index | Baseline | .21 units on a scale | Standard Deviation 0.12 |
| Individual Drug Counseling | Addiction Severity Index (ASI) Drug Composite Index | Mid Treatment | .16 units on a scale | Standard Deviation 0.1 |
| Individual Drug Counseling | Addiction Severity Index (ASI) Drug Composite Index | Treatment Endpoint | .18 units on a scale | Standard Deviation 0.13 |
| Individual Drug Counseling | Addiction Severity Index (ASI) Drug Composite Index | Follow Up 1 | .18 units on a scale | Standard Deviation 0.11 |